Trial Information

Surgery for Endometrial Cancer: Biobehavioral Analysis of Sleep, Stress and Pain

Despite continuing improvements in surgical procedures and ancillary care, post surgery pain
continues to be a nearly universal patient experience following major operative procedures.
Opioids provide considerable pain relief, but they have multiple adverse side effects and
are not entirely effective. For cancer patients, uncontrolled postoperative pain can have a
substantial negative effect on quality of life, can slow recovery, increase the likelihood
of complications, and contribute to poorer postoperative outcomes. The identification of
novel modifiable patient risk factors for post surgery pain that could become the target of
presurgery interventions is thus an important goal. We will conduct a randomized,
placebo-controlled, double-blind intervention trial design to evaluate the effects of an FDA
approved hypnotic (zolpidem) on post surgery pain. Since presurgery psychological factors
(e.g., heightened anxiety) are known to predict the severity of post surgical pain and may
be associated with poor sleep, we will also assess psychological factors (with
questionnaires) as well as sleep (using actigraphy) in order to determine their individual
and combined impact on women's experiences of post surgery pain in this stressful clinical
context. Aim 1: To determine the impact of zolpidem administered the night prior to
endometrial cancer surgery on women's experiences of pain over the initial 7-10 day
follow-up period after surgery using a double-blind placebo-controlled design (final n=128).
Aim 2: To investigate psychological factors on the morning before surgery, as well as
objective sleep variables on the night before surgery, as possible mediators of the
beneficial effects of zolpidem on post surgery pain. Aim 3: To examine psychological
factors, as well as sleep variables, assessed prior to the sleep intervention as possible
moderators of the ameliorative effects of zolpidem on post surgery pain. The results of the
proposed exploratory study would provide the preliminary data necessary for an R01
application to support more comprehensive investigations, including explorations of
biological mechanisms underlying the preventative effects of better presurgery sleep on
patients' experiences of post surgery pain.